Regulatory Affairs Consulting
The American College of Regenerative Medicine offers assistance with your Phase I, II and III clinical trial submissions. We are able to function as your Head of Regulatory Affairs to prepare and submit Investigational New Drug (IND) applications to the FDA.
With years of IND filing experience our experts can participate in meetings with the FDA and guide the acquisition of pertinent information required for IND submission, including necessary preclinical data and manufacturing information – a critical step in the application and approval process.
Regulatory filings and agency interactions include the following:
Creating Meeting Requests
Authoring Briefing Documents
Agency Meeting Participation
Agency Feedback Assessment
PI Change, Addition and Removal
FDA Adverse Event Reporting
FDA Serious Adverse Event Reporting
Regulatory Project Management
Regulatory Activity SOP Development
FDA & EU Remediation (483 Observations, Warning Letters, Consent Decrees)